Latest Publications


Declaratory Judgment Litigation Brought by Biosimilar Manufacturers

Courts have begun to shape the contours of the Biologics Price Competition and Innovation Act (“BPCIA”) and the progress of biosimilar litigation, but the use of declaratory judgment actions by biosimilar manufacturers...more

Biosimilars 2017 Year in Review

Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more

Federal Circuit Simplifies BPCIA Disputes by Finding State Remedies Preempted

The Amgen v. Sandoz battle continues to make new law regarding the Biologics Price Competition and Innovation Act (“BPCIA”), this time in a December 14th ruling from the Federal Circuit finding that “the BPCIA preempts state...more

The Herceptin® Battle Moves into the District Court

On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more

Federal Circuit Provides Guidance on Probative Value of “Patent Dance” Letters and aBLA Parameters in an Infringement Analysis

On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...more

The Ramifications of Leaving the Patent Dance Floor

While the Supreme Court held in Amgen v. Sandoz that biosimilar applicants cannot be forced with a federal injunction to provide a copy of their biosimilar application (aBLA) and manufacturing information to the reference...more

Kyle Bass Ends with a Bang: Success in Final PTAB Decision

On June 7, 2017, Kyle Bass received his last final written decision in a long list of PTAB decisions rendered over the past two years as Kyle Bass sought to invalidate pharma patents. U.S. Patent No. 8,476,010 (the “’010...more

Thought Leaders Gather at 8th Annual ACI Biosimilars Summit

This week, the American Conference Institute (ACI) held its 8th annual summit on biosimilars in New York City to discuss the latest developments in the field. ACI chose its timing well, as the Supreme Court released its...more

SCOTUS Unravels Some of the BPCIA Enigma — But Questions Remain

Reference product sponsors (RPSs) and biosimilar manufacturers were hoping the Supreme Court of the United States would clarify two aspects of the Biologics Price Competition and Innovation Act (“BPCIA”) in the Amgen v....more

Kyle Bass Does Not Seek to Uphold PTAB Decisions on Appeal

Over the past few years, Kyle Bass has sought to invalidate pharma patents that he believes should have never been granted, and that he claims artificially inflate the costs of certain drugs, through the inter partes review...more

The Last “Cabilly” Challenge Quietly Settles

U.S. Pat. No. 6,331,415, commonly referred to as “Cabilly II,” has been called one of the most-litigated patents of all time, having been challenged multiple times in both the district court and at the U.S. Patent and...more

How Soon Can A Biosimilar Applicant Be Sued for Patent Infringement?

Biosimilar manufacturers proceeding under the abbreviated approval pathway laid out in the Biologics Price Competition and Innovation Act (“BPCIA”) open themselves up to patent infringement litigation. But how soon can a...more

Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars

Protective orders that regulate the disclosure and use of confidential information exchanged during patent litigations are commonplace. However, the patent dispute resolution procedures under the Biologics Price Competition...more

A Mixed Bag for Kyle Bass: Three Wins and Eight Losses at the PTAB

Over the past two years, hedge fund manager Kyle Bass has continued his efforts to invalidate biopharma patents through inter partes review (“IPR”). Over the past month, he received eleven final written decisions from the...more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Rituxan® Patents Resurface at the PTAB

Two patents related to methods of treating rheumatoid arthritis (RA) patients with rituximab have been brought before the PTAB for a third time – with mixed results. The challenged patents are U.S. Patent Nos. 7,976,838...more

Fish & Richardson’s Post-Grant Report 2016

2016 marked the fourth anniversary of the America Invents Act (AIA). The Patent Trial and Appeal Board (PTAB) was once again the forum of choice for challenging patentability of claims, surpassing the Eastern District of...more

Genentech Seeks “Urgent” Relief from Amgen’s Alleged BPCIA Violations

On February 15, Genentech filed a complaint against Amgen in the District of Delaware seeking “urgent declaratory and related relief” under the Biologics Price Competition and Innovation Act (“BPCIA”). Unlike many other...more

Biosimilar Litigants Square Off Before the Supreme Court

Last week, Sandoz filed its opening Supreme Court brief, asking the Court to determine (1) whether notice of commercial marketing under Subsection (l)(8)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) is...more

Dance Partners Janssen and Celltrion Face Off in Trial Scheduled for February 2017

Only U.S. Patent No. 7, 598, 083 (“the ‘083 patent”) remains at issue in Janssen’s suit against Celltrion and Hospira in the District of Massachusetts (C.A. No. 1:15-cv-10698) relating to a biosimilar of Janssen’s Remicade®...more

Inflectra® Biosimilar Patent Litigation—The Remedies Dispute

A pending patent-infringement case, litigated under the Biologics Price Competition and Innovation Act (“BPCIA”), will present several new questions related to how the BPCIA will interact with patents on biosimilar...more

Janssen Files Opening Appeal Brief in Attempt to Revive Remicade® Patent

Janssen has fired its opening salvo in its attempt to overturn two invalidity rulings at the district court level and one invalidity ruling at the PTAB with respect to U.S. Patent No. 6,284,471 (the ’471 patent) covering...more

Biosimilars: What to Expect in 2017

2016 was a record year for the development of biologics in the United States. Below, we summarize a few key biosimilar developments to keep an eye on in 2017. SCOTUS Review of Amgen v. Sandoz - In 2016, Amgen,...more

Patent Challengers Must Show Harm to Appeal Final PTAB Decisions

Last week, the Federal Circuit for the first time addressed the legal standard for demonstrating standing in an appeal from a final agency decision, such as an inter partes review (IPR) decision. Phigenix, Inc. v. ...more

Amgen v. Sandoz: SCOTUS to Solve the Riddle Wrapped in a Mystery Inside an Enigma

Last week, the United States Supreme Court granted certiorari review of the Amgen v. Sandoz decision. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015), cert. granted, (U.S. Jan. 13, 2017). In Amgen v. Sandoz,...more

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